Pembrolizumab and nivolumab
Response to a request for information on funded PD-1 inhibitors (pembrolizumab and nivolumab).
25 November 2019
[name and contact details redacted]
Dear [name redacted]
REQUEST FOR INFORMATION
Thank you for your request dated 30 October 2019 under the Official Information Act 1982 (OIA) for information relating to pembrolizumab and nivolumab. Your request was:
PD-1 indication |
Epidemiological Data / Patient Number Assumptions |
First-line non small cell lung cancer |
|
Second-line non small cell lung cancer |
|
First-line melanoma |
Note: As this indication is already listed on the Pharmaceutical Schedule, it would be useful for us to understand:
|
Adjuvant melanoma |
|
Renal cell carcinoma |
|
First-line non-small cell lung cancer (NSCLC)
PHARMAC estimates approximately 1200 patients a year would be eligible for first-line metastatic NSCLC.
This estimate of the size of the patient population does not include consideration of histology, mutation status and PD-1 status. The various Special Authority criteria proposed by our clinical advisors specify that patients must be treatment naïve for metastatic disease, therefore only newly diagnosed patients would be eligible.
We consider there is unlikely to be a significant group of prevalent metastatic NSCLC patients who have not yet received any treatment for their metastatic disease.
Second-line non-small cell lung cancer
PHARMAC estimates there would be 600-800 eligible second-line NSCLC patients a year acknowledging there is significant uncertainty in this estimate.
This estimate of the size of the patient population does not include consideration of histology, mutation status and PD-1 status. Also note, due to the short natural history of the disease we do not expect a significant prevalent population who have received previous first-line treatment for their metastatic disease.
First-line melanoma
New Special Authority initiations per month, financial year 2018-19 (source, Pharmhouse)
Month |
New patients |
Total patients |
July 2018 |
24 |
233 |
August 2018 |
25 |
253 |
September 2018 |
30 |
269 |
October 2018 |
25 |
267 |
November 2018 |
27 |
272 |
December 2018 |
19 |
262 |
January 2019 |
24 |
266 |
February 2019 |
29 |
284 |
March 2019 |
30 |
297 |
April 2019 |
21 |
298 |
May 2019 |
34 |
310 |
June 2019 |
28 |
316 |
Total annual patient numbers, PD-1 inhibitors.
Year |
Number of patients |
2016/17 |
361 |
2017/18 |
432 |
2018/19 |
545 |
Adjuvant melanoma
An application for funding of pembrolizumab for an adjuvant treatment for resected Stage III melanoma was received in February 2019. Clinical advice has been sought from PTAC in August 2019 and the Cancer Treatments Subcommittee (CaTSoP) in October 2019. Details of this application can be found on our Application Tracker at https://connect.pharmac.govt.nz/apptracker/s/application-public/a102P000008ptx2/(external link)
While we have not yet undertaken economic assessment of this application, our clinical advice indicates the following regarding patient numbers (PTAC minutes (minute 7.33):
“The Committee noted the supplier estimate of approximately 334 patients being suitable for this treatment in the first year (due to a backlog), with fewer patients in subsequent years. The Committee considered this estimate could be too high, however, noting the potential for increased referral from plastic surgery and dermatology services if pembrolizumab were to be funded in this setting. The Committee considered that CaTSoP or Oncology Societies in New Zealand may be able to better estimate patient number”.
Renal cell carcinoma (RCC)
PHARMAC staff have not yet assessed patient numbers for PD-1 inhibitors in a first-line setting for advanced renal cell carcinoma. The number of patients receiving currently funded first-line treatment for RCC (either sunitinib or pazopanib) is approximately 520 patients a year.
Recent PHARMAC analysis of the second-line RCC population has assumed a patient population of 420 patients a year would be eligible for PD-1 inhibitors in this setting following progression on either pazopanib or sunitinib.
We are aware these estimates have considerable uncertainty, however we are in the process of updating them.
PHARMAC approaches its assessment of requests for information under the OIA on the basis that, once released, the information becomes publicly available - in other words once we release the information to you it becomes available to any other party in that exact form (whether by you distributing it to others or by virtue of us receiving the same request from a different third party).
We trust that this information answers your queries. We are making our information more freely available, so we will now publish selected OIA responses (excluding personal details) on our website. Please get in touch with us if you have any questions about this.
Yours sincerely
Alison Hill
Director, Engagement and Implementation